Measurement of Mucosal Biomarkers in a Phase 1 Trial of Intravaginal 3% StarPharma LTD 7013 Gel (VivaGel) to Assess Expanded Safety

Department of Pediatrics, University of California, San Francisco, CA 94118, USA.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.56). 11/2011; 59(2):134-40. DOI: 10.1097/QAI.0b013e31823f2aeb
Source: PubMed


The aim of this study was to examine the effect of the 3% StarPharma LTD 7013 gel (VivaGel) on mucosal immune markers hypothesized to be associated with HIV-1 acquisition.
Phase 1, placebo-controlled, randomized, double-blind clinical trial was performed in 54 young women in the United States and Kenya. Participants used carbopol gel with and without (placebo) StarPharma LTD 7013 twice daily over 14 days. Cervical specimens were collected for cytokines, chemokines, T cells, and dendritic cells at days 0, 7, 14, and 21. A negative binomial regression model was used to assess differences between study arms.
Several mucosal immune parameters were increased in the VivaGel arm compared with placebo. For cytokines D7, IL-6 (P = 0.05); D 14, interferon gamma (P = 0.03), IL-2 (P = 0.04), IL-5 (P = 0.003), and IL-10 (P = 0.001) were increased. On D7, CD8+/CD69+ T cells tended to be increased (P < 0.08); limiting analysis to visits without blood or bacterial vaginosis, these findings were stronger as follows: at D7, CD8+/CD69+ T cells were increased in the VivaGel arm (P < 0.005), as were CD4+/CD69+ cells (P = 0.001) and CD4+/CCR5+ T cells (P = 0.01). The changes described for D7 and 14 were no longer seen at D21.
Markers associated with inflammation and epithelial damage were reversibly elevated in the VivaGel arm compared with the placebo arm after 7-14 days of twice daily product use.

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    • "This is the first clinical evidence of the efficacy of the VivaGel Ò and it may be possible to administer VivaGel Ò 3 h before coitus [16]. In a recent Phase I trial, Mosicicki et al., evaluated the effect of VivaGel treatment on various mucosal biomarkers associated with epithelial damage [17]. It was observed that VivaGel treated women showed higher levels of IFN-g, IL-2, IL-5, IL-6 and IL- 10 after 7-day and/or 14-day administration. "
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